daily nitrofurantoin versus bladder fulguration plus daily nitrofurantoin for women with recurrent urinary tract infections

Conditions: Recurrent UTIs; Cystitis Recurrent

Summary: the goal of this clinical trial is to learn if the drug nitrofurantoin (nf) taken as a daily antibiotic, works to treat cystitis compared to electrofulguration (ef) and nitrofurantoin (nf) daily antibiotic.

this is a study for women age 18 -85 with a well-documented history of ruti (recurrent urinary tract infection) for at least one year. this randomized multicentric clinical trial will determine the efficacy of conventional 6 months nitrofurantoin (nf) daily antibiotic prophylaxis alone versus electrofulguration (ef) associated with a 6 months nf daily antibiotic prophylactic course for early stages of chronic cystitis (stages 1 and 2) as determined on office cystoscopy. this study will ask the participant (n=104) to return to the urology clinic at ut southwestern medical center (n=52) or the university of kansas medical center (n=52) for a total of 8 compensated visits throughout 30 months after the start of this randomized trial to make sure that the treatment worked well for them.

Eligibility criteria:
inclusion criteria: * females 18 to 85 years old with at least a 1-year history of culture documented uncomplicated ruti. * diagnosis of ruti, defined as ≥ 3 symptomatic utis in 12 months or ≥ 2 in 6 months. * currently free from a uti determined based on absence of symptoms as determined by the uti symptom assessment questionnaire and negative urine culture (\<10\^3 colony forming units per ml of urine). * a negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than or equal to stage 2), measurement of post-void residual (less than 50 ml), and imaging (which may include renal ultrasound and standing voiding cystourethrogram) to exclude kidney stone, hydronephrosis, reflux, or urethral diverticulum. * office cystoscopy documenting stages 1 or 2 of chronic cystitis. * likely to stay in the geographic region for the duration of the study. * asa class ii or less. exclusion criteria: * patients on antibiotics at baseline (i.e., suppressive therapy or antibiotic therapy for non-urinary infections). * patients on self-start therapy (i.e., taking antibiotics upon start of urinary symptoms concerning for uti). * patients on prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months. * complicated utis, including neurogenic bladder condition (i.e., multiple sclerosis, parkinson's disease, spinal cord injury), bladder augmentation, or urinary diversion. * patients with urinary catheters (including indwelling foley, intermittent catheterization, and suprapubic catheters). * uncontrolled diabetes (hba1c \>9). * pregnancy * allergy or resistance to nitrofurantoin. * chronic lung or liver condition precluding the use of nitrofurantoin, including abnormal chest x ray or elevated liver function tests. * chronic renal insufficiency (creatinine over 1.5 g/dl or gfr less than 40) precluding the use of nitrofurantoin. * history of chronic diarrhea requiring regular therapy. * patients with psychosis, dementia, swallowing disorders, or any other ability to take nitrofurantoin reliably at home. * bmi over 40. * use of uromune or other vaccine approaches to reduce ruti episodes * participation in a research study involving an investigational product in the past 12 weeks. * patients receiving phage therapy. * current diagnosis of interstitial cystitis. * patients with medical conditions requiring excessively large amounts of fluid intake.

Keywords: bladder fulguration nitrofurantoin long-term managenent of cystitis recurrent uti chronic uti